Job Description

Las Visión de Conjunto

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

We are the people behind the people who keep saving lives.

Responsabilidades

Supervises product analysis lab activities related to medical or other devices manufactured and/or distributed. Ensure that the product analysis processes are followed appropriately. Leads the product analysis laboratory processes across all parts of the organization.

ESSENTIAL DUTIES ANDRESPONSIBILITIES:

• Ensures the product analysis process is established to maintain compliance with all regulations.
• Accountable for compliance with all Food & Drug Administration (FDA), European Union Medical Device Directives (MOD) and other regulations governing adverse event reports such as Medical Device Reports (MOR), Medical Device Vigilance (MDV) and other vigilance reports worldwide.
• Under the direction of department management, is an active participant during internal and external audits.
• Designs and delivers results oriented technical training programs, including Global complaint handling system and departmental processes and procedures.
• Performs periodic audits of product analysis analysts' activities to ensure compliance with departmental procedures.
• Reviews audit responses and assist with required training in response to audit findings and other related issues as needed.
• May evaluate failure analysis findings for appropriateness and any significant issues.
• Supervises department operations and professional employee(s)
• Participate in the development of policies and procedures to achieve specific goals regarding the product analysis lab procedures.
• Interacts with subordinates, peer customers and suppliers at various management levels for issues related to the worldwide complaint handling process.
• Supervises staff to complete escalation requests for all products and ensures all regulatory requirements are maintained.
• Practices company safety, quality policies and procedures, actively requires conformance.
• Develops improvements to existing complaint processing system.
• Creates systems for compiling metrics of product analysis.
• Supervises staff to resolve complaints and product evaluations for all products and ensures all regulatory requirements are maintained.
• Provides direction and leadership for the investigation and resolution of all product evaluations in a timely manner.
• Sets departments goals and metrics and supervises team for optimal performance.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets.
• Performs other duties assigned as needed

Calificaciones

Required Qualifications

University degree or the equivalent combination of education and experience required. Requires a total minimum of 4+ years of relevant experience.

Preferred Qualifications

• 8+ years of related experience and/or training
• System implementation experience a plus
• Experience in the medical device industry would be an asset

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

• Excellent written and oral English communication skills
• Proficient investigative and analytical skills
• Computer literate of MS Word, MS PowerPoint, MS Excel a plus
• Ability to interact within individual/groups at all levels, good presentation/training skills
• Ability to identifypriorities and function independently
• Supervisoryexperience

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.